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Engineering Documentation Expert

Katalyst Healthcares and Lifesciences

•

Fort Worth, Texas, USA

Full-time

Responsibilities: Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices. Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements. Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems. Collaborate with R&D and manufacturing
Posted 60+ days ago | Updated 4 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

•

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 60+ days ago | Updated 4 hours ago

Engineer III

Katalyst Healthcares and Lifesciences

•

Flemington, New Jersey, USA

Full-time

Roles & Responsibilities: Process non-conformances and CAPAs following approved procedures. Perform investigations and assist in problem solving following approved methodologies. Partners with engineering, production, maintenance, etc. to maintain/increase the quality level within the organization. Ensures local issues are incorporated into global total quality management plans, taking legal requirements and local manufacturing processes into consideration. Monitors quality control processe
Posted 25 days ago | Updated 4 hours ago

Injection Molding Engineer

Johnson & Johnson

•

Jacksonville, Florida, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 4 hours ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 60+ days ago | Updated 4 hours ago

Medical Device System Test Engineer

Katalyst Healthcares and Lifesciences

•

Raleigh, North Carolina, USA

Full-time

Responsibilities: Develop system and subsystem-level design specifications based on requirements. Develop system and subsystem-level configurations. Develop system and subsystem-level test methods and protocols. Serve as design transfer liaison to Manufacturing, Service, Support, and Training. Serve as technical support for key products to our customers, dealers and field engineers. Prototype and test new circuit boards and improved revisions of existing circuit boards following medical de
Posted 60+ days ago | Updated 4 hours ago

Injection Mold Engineer

Johnson & Johnson

•

Jacksonville, Florida, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 4 hours ago

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

•

Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute
Posted 60+ days ago | Updated 4 hours ago

Principal R&D Engineer

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Schedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design
Posted 60+ days ago | Updated 4 hours ago

Validation Engineer NPI

Katalyst Healthcares and Lifesciences

•

Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical
Posted 60+ days ago | Updated 4 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 2 days ago | Updated 4 hours ago

Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA)

Philips North America

•

Plymouth, Minnesota, USA

Full-time

Job Title Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA) Job Description Principal Software Architect- Clinical Imaging Software (Plymouth, MN or Cambridge, MA) We are seeking an experienced and visionary Principal Software Architect to lead the architectural direction of our Clinical Imaging Software portfolio for the Image Guided Therapy Devices (IGT-D) business. As a key member of the Software Leadership team, you will be responsible for shaping in
Posted 19 days ago | Updated 4 hours ago

Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app
Posted 60+ days ago | Updated 4 hours ago

Software Verification Engineer

Katalyst Healthcares and Lifesciences

•

Newton, Massachusetts, USA

Full-time

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects. Responsibilities: Test Planning and Design. Develop comprehensi
Posted 50 days ago | Updated 4 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 7 days ago | Updated 4 hours ago

Systems Engineer

Katalyst Healthcares and Lifesciences

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Skaneateles, New York, USA

Full-time

Responsibilities: Responsible for integration of design and manufacturing process procedures, templates and guidance documents within an ISO 13485 compliant Quality Management System (QMS). Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of Syste
Posted 60+ days ago | Updated 4 hours ago

Principal Validation Engineer

Johnson & Johnson

•

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 41 days ago | Updated 4 hours ago

Engineer III, Systems Engineer

Katalyst Healthcares and Lifesciences

•

San Diego, California, USA

Full-time

Responsibilities: Verification & validation Engineer will have the following responsibilities: A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical
Posted 16 days ago | Updated 4 hours ago

Engineer

ACL Digital

•

Thousand Oaks, California, USA

Full-time

Onsite This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA. The candidate will support senior staff in device development, characterization, and verification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects. This role will be required t
Posted 2 days ago | Updated 4 hours ago

Engineering Technician- Temp Contract

10x Genomics

•

Pleasanton, California, USA

Full-time

About the role: We are seeking an organized, detail-oriented, problem-solving individual to join our Life Cycle Engineering team. The successful candidate will have strong attention to detail, great communication skills, ability to prioritize a variety of tasks, and the ability to work independently in a fast-paced environment. The Engineering Technician supports engineers so they can keep developing our manufacturing workcells and equipment. Our products have allowed researchers to study biolo
Posted 31 days ago | Updated 4 hours ago